BehaviorNCT03065296
Standardized Home Exercise Prescription Education
A study testing Musculoskeletal (MSK) Prescription Didactic Lectures and Musculoskeletal (MSK) home exercise hand-outs in people with Behavior and Knowledge, Attitudes, Practice, run by University of Florida.
Trial summary
This project will encompass an evaluation of the educational value of having evidence based home exercise protocols available for family medicine residents in regard to the prescription of home exercise treatment for common musculoskeletal conditions. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Knowledge, Attitudes, Practice
- What is being tested?
- Musculoskeletal (MSK) Prescription Didactic Lectures and Musculoskeletal (MSK) home exercise hand-outs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident of the Family Medicine Department at the University of Florida.
Who cannot join
- None
About this study
Official title: Standardized Home Exercise Prescription: Education of Family Medicine Residents
This project will encompass an evaluation of the educational value of having evidence based home exercise protocols available for family medicine residents in regard to the prescription of home exercise treatment for common musculoskeletal conditions. Investigators will be evaluating resident knowledge on home exercise prescription as well as their level of comfort in educating their patients before and after a series of didactic sessions and implementation of exercise protocols.
Read the detailed description
This study aims to fill the gap in this area of the literature pertaining to home exercise prescription. The justification of this study's scientific merit comes from the lack of literature and the need for research in this area. There have been multiple studies that have shown different exercise modality treatments for common musculoskeletal (MSK) complaints significantly improve both disability and overall quality of life. Despite the evidence of the short and long term effectiveness of exercise based therapies, there is a general lack of confidence of residents in prescribing and teaching patients rehab exercises.Additionally, many of the patients seen in the University of Florida (UF) Family medicine residency program cannot afford or do not have time to attend physical therapist led rehab sessions. This makes physician led education and the ability of prescribing exercise based treatments for musculoskeletal (MSK) complaints a very important component of patient care.
- Conditions
- Behavior, Knowledge, Attitudes, Practice
- Being tested
- Musculoskeletal (MSK) Prescription Didactic Lectures, Musculoskeletal (MSK) home exercise hand-outs
- Keywords
- Behavior, education, medical residents, knowledge, confidence, skills assessment
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal (MSK) Prescription Didactic LecturesBehavioural
In between phase 1 and phase 2 there will be a series of didactic lectures to educate resident on home exercise prescription and get them familiarized with the handouts.
Musculoskeletal (MSK) home exercise hand-outsOther
In between phase 1 and phase 2, residents will use home exercise hand-outs readily available and educate their patients in regards to those.
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal (MSK) Exercise Prescription | Experimental | * Phase I: Residents will be surveyed as to their knowledge and confidence in both diagnosing specific musculoskeletal (MSK) issues and prescribing the correct home rehabilitation regimen.
* In between phase 1 and phase 2 there will be a series of didactic lectures to educate resident on home exercise prescription and get them familiarized with the handouts.
* Phase II: Residents will be surveyed again in May 2017 with the same multiple choice questions and Likert style confidence scales from phase 1
The survey will consist of multiple choice and short essay questions, focused on the most common musculoskeletal (MSK) injuries seen in the primary care setting. Receives: Behavioral: Musculoskeletal (MSK) Prescription Didactic Lectures; Other: Musculoskeletal (MSK) home exercise hand-outs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in knowledge about Musculoskeletal (MSK) Exercises
Knowledge scores should be at least overall 80% regarding MSK rehabilitation exercises.
Measured: at 6 months
Confidence in educating patients about Musculoskeletal (MSK) Exercises
Improvement of at least 20% in Medical Residents' confidence regarding education of Musculoskeletal (MSK) to patients
Measured: at 6 months
Secondary outcomes (2)
Confidence in prescribing Musculoskeletal (MSK) Exercises to patients
Improvement of at least 20% in Medical Residents' confidence regarding prescription of Musculoskeletal (MSK) exercises
Measured: at 6 months
Improvement in prescribing Musculoskeletal (MSK) Exercises to patients
Prescription scores should be at least overall 80% regarding MSK rehabilitation exercises
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start15 Mar 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Why it stopped: The Investigator left the institution and was withdrarwn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlie Michaudet, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065296
- Sponsor's protocol ID
- IRB201602626
- Status last verified
- Nov 2017
- First submitted
- 17 Feb 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Home Exercise Prescription: Education of Family Medicine Residents
- ClinicalTrials.gov ID
- NCT03065296
- Acronym / sponsor ID
- IRB201602626
- Conditions
- Behavior, Knowledge, Attitudes, Practice
- Keywords
- Behavior, education, medical residents, knowledge, confidence, skills assessment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Investigator left the institution and was withdrarwn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will encompass an evaluation of the educational value of having evidence based home exercise protocols available for family medicine residents in regard to the prescription of home exercise treatment for common musculoskeletal conditions. Investigators will be evaluating resident knowledge on home exercise prescription as well as their level of comfort in educating their patients before and after a series of didactic sessions and implementation of exercise protocols.
Detailed description
This study aims to fill the gap in this area of the literature pertaining to home exercise prescription. The justification of this study's scientific merit comes from the lack of literature and the need for research in this area. There have been multiple studies that have shown different exercise modality treatments for common musculoskeletal (MSK) complaints significantly improve both disability and overall quality of life. Despite the evidence of the short and long term effectiveness of exercise based therapies, there is a general lack of confidence of residents in prescribing and teaching patients rehab exercises.Additionally, many of the patients seen in the University of Florida (UF) Family medicine residency program cannot afford or do not have time to attend physical therapist led rehab sessions. This makes physician led education and the ability of prescribing exercise based treatments for musculoskeletal (MSK) complaints a very important component of patient care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal (MSK) Exercise Prescription | Experimental | Behavioral: Musculoskeletal (MSK) Prescription Didactic Lectures, Other: Musculoskeletal (MSK) home exercise hand-outs* Phase I: Residents will be surveyed as to their knowledge and confidence in both diagnosing specific musculoskeletal (MSK) issues and prescribing the correct home rehabilitation regimen. * In between phase 1 and phase 2 there will be a series of didactic lectures to educate resident on home exercise prescription and get them familiarized with the handouts. * Phase II: Residents will be surveyed again in May 2017 with the same multiple choice questions and Likert style confidence scales from phase 1 The survey will consist of multiple choice and short essay questions, focused on the most common musculoskeletal (MSK) injuries seen in the primary care setting. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resident of the Family Medicine Department at the University of Florida.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musculoskeletal (MSK) Prescription Didactic LecturesIn between phase 1 and phase 2 there will be a series of didactic lectures to educate resident on home exercise prescription and get them familiarized with the handouts. | Behavioural | Musculoskeletal (MSK) Exercise Prescription |
| Musculoskeletal (MSK) home exercise hand-outsIn between phase 1 and phase 2, residents will use home exercise hand-outs readily available and educate their patients in regards to those. | Other | Musculoskeletal (MSK) Exercise Prescription |
Primary outcome
Improvement in knowledge about Musculoskeletal (MSK) Exercises
Time frame: at 6 months
Knowledge scores should be at least overall 80% regarding MSK rehabilitation exercises.
Confidence in educating patients about Musculoskeletal (MSK) Exercises
Time frame: at 6 months
Improvement of at least 20% in Medical Residents' confidence regarding education of Musculoskeletal (MSK) to patients
2 secondary outcomes
Confidence in prescribing Musculoskeletal (MSK) Exercises to patients
Time frame: at 6 months
Improvement in prescribing Musculoskeletal (MSK) Exercises to patients
Time frame: at 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Michaudet, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Musculoskeletal (MSK) Prescription Didactic Lectures and Musculoskeletal (MSK) home exercise hand-outs in people with Behavior and Knowledge, Attitudes, Practice, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in knowledge about Musculoskeletal (MSK) Exercises (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.